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临床试验/NCT03429322
NCT03429322已完成不适用

Testing an Integrated Medical and Resource Facilitation Intervention After Traumatic Brain Injury: A Community-based Pragmatic Clinical Trial

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 415 人开始时间: 2019年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
415
试验地点
2
主要终点
Change in Traumatic Brain Injury-Quality of Life (TBI-QOL)

研究概览

简要总结

Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will address chronic unmet needs expressed by individuals with TBI and their families in the U.S. pertaining to the ineffective connection to specialized medical and community resources in the transition from hospital to community-based care, limited access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex needs of individuals with TBI. Target populations for this study are: 1) individuals with TBI eligible for MN BIA provided Resource Facilitation (RF), 2) their families, and 3) their PCPs.

This clinical trial will use a theory-driven complex behavioral intervention that integrates the medical-rehabilitation, therapy, and TBI expertise of Mayo's Brain Rehabilitation Clinic (BRC) with MN BIA's highly developed RF program (a free two-year telephone support service offering assistance in navigating life after brain injury). Mayo Clinic's medical-rehabilitation expertise will be integrated with RF services to deliver direct clinical care remotely using telemedicine and other information and communication technology to test whether outcomes over time are better in a group receiving this model of care compared to a group that receives usual care in their communities.

Costs between usual care and intervention groups will be compared in collaboration with the MDH. The overarching goal is development of a replicable, sustainable, and cost effective model of telemedicine care that integrates TBIMS Centers and BIAs nationwide and builds TBI expertise and capacity among PCPs.

详细描述

This Integrated Medical and Resource Facilitation Intervention (MRFI) trial will address: 1) The ineffective connection of individuals with traumatic brain injury (TBI) and their families to specialized medical and community resources after hospital-based care; 2) Limited access to TBI experts, and; 3) A lack of knowledge by primary care providers (PCP) about the complex needs of individuals with TBI.

This clinical trial will test a theory-driven complex behavioral intervention that integrates the medical and TBI expertise of Mayo's Brain Rehabilitation Clinic (BRC) with Minnesota Brain Injury Alliance's (MN BIA) highly developed Resource Facilitation (RF) program.

The target populations for the proposed study are: 1) Individuals with TBI eligible for MN BIA RF services; 2) Their families or caregivers; and 3) Their PCPs.

This research uses a community-based pragmatic clinical trial (PCT) to test a complex behavioral intervention. A PCT: 1) Compares multiple clinically relevant interventions rather than comparing an intervention of interest against a placebo or control condition; 2) Includes a heterogeneous population of participants in multiple experimental settings as opposed to a narrowly controlled homogeneous sample in practice settings of a single kind; and 3) Measures a broad range of health care outcomes.

The active elements in the proposed trial define a 'complex behavioral intervention'. The intervention's integrated MRFI model of care consists of: multiple components within the experimental and control interventions that interact; multiple and complex behaviors associated with those delivering and receiving the intervention; multiple target populations; multiple outcome measurements; and, adapting the intervention based on need and context.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Traumatic Brain Injury-Quality of Life (TBI-QOL)

时间窗: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

Measures health-related patient-reported quality of life measurement specific to TBI

Change in Participation Assessment with Recombined Tools-Objective (PART-O)

时间窗: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

Measures long-term outcomes and function at the societal level

Change in Mayo-Portland Participation Index (M2PI)

时间窗: Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

A primary participation assessment and outcome measure for phone follow-up

次要结局

  • Change in Telemedicine Perception Questionnaire (TMP-Q)(Collected 3 times: enrollment, midpoint (6 months), and study end (18 months))
  • Change in Family Needs Questionnaire (FNQ)(Collected 3 times: enrollment, midpoint (6 months), and study end (18 months))
  • Change in Vocational Independence Scale(Collected 3 times: enrollment, midpoint (6 months), and study end (18 months))
  • EQ-5D™(Assessed at study end (18 months))
  • Change in Zarit Burden Inventory (ZBI)(Collected 3 times: enrollment, midpoint (6 months), and study end (18 months))
  • Change in Clinical Satisfaction and Competency Rating Scale (CSCRS)(Collected 3 times: enrollment, midpoint (6 months), and study end (18 months))

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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